Opzelura is a drug owned by Incyte Corp. It is protected by 28 US drug patents filed from 2021 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 05, 2041. Details of Opzelura's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8722693 | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
| US7598257 | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors |
Dec, 2027
(3 years from now) | Active |
| US8415362 | Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Dec, 2027
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11602536 | Topical treatment of vitiligo by a JAK inhibitor |
May, 2041
(16 years from now) | Active |
| US11590137 | Ruxolitinib formulation for reduction of itch in atopic dermatitis |
Sep, 2040
(15 years from now) | Active |
| US11510923 | Ruxolitinib formulation for reduction of itch in atopic dermatitis |
Sep, 2040
(15 years from now) | Active |
| US11590138 | Topical treatment of vitiligo by a jak inhibitor |
Jun, 2040
(15 years from now) | Active |
|
US11219624 (Pediatric) | Topical formulation for a JAK inhibitor |
Nov, 2031
(6 years from now) | Active |
|
US10758543 (Pediatric) | Topical formulation for a JAK inhibitor |
Nov, 2031
(6 years from now) | Active |
|
US10869870 (Pediatric) | Topical formulation for a JAK inhibitor |
Nov, 2031
(6 years from now) | Active |
| US11571425 | Topical formulation for a JAK inhibitor |
May, 2031
(6 years from now) | Active |
| US10869870 | Topical formulation for a JAK inhibitor |
May, 2031
(6 years from now) | Active |
| US11590136 | Topical formulation for a JAK inhibitor |
May, 2031
(6 years from now) | Active |
| US10758543 | Topical formulation for a JAK inhibitor |
May, 2031
(6 years from now) | Active |
| US11219624 | Topical formulation for a JAK inhibitor |
May, 2031
(6 years from now) | Active |
|
US8822481 (Pediatric) | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US8722693 (Pediatric) | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US10610530 (Pediatric) | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US8415362 (Pediatric) | Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Jun, 2028
(3 years from now) | Active |
|
US7598257 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors |
Jun, 2028
(3 years from now) | Active |
| US10610530 | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
| US8822481 | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
|
US9079912 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors |
Jun, 2027
(2 years from now) | Active |
|
US9974790 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors |
Jun, 2027
(2 years from now) | Active |
|
US10639310 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US10639310 | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Dec, 2026
(2 years from now) | Active |
| US9079912 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors |
Dec, 2026
(2 years from now) | Active |
| US9974790 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors |
Dec, 2026
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Opzelura's patents.
Latest Legal Activities on Opzelura's Patents
Given below is the list of recent legal activities going on the following patents of Opzelura.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Jun, 2024 | US10869870 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Mar, 2024 | US10758543 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Nov, 2023 | US10639310 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2023 | US10610530 |
| Electronic Review Critical | 17 May, 2023 | US11602536 |
| Post Issue Communication - Certificate of Correction | 26 Apr, 2023 | US11602536 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Mar, 2023 | US11602536 |
| Recordation of Patent Grant Mailed Critical | 14 Mar, 2023 | US11602536 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Feb, 2023 | US11590136 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Feb, 2023 | US11590137 |
FDA has granted several exclusivities to Opzelura. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Opzelura, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Opzelura.
Exclusivity Information
Opzelura holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Opzelura's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 21, 2024 |
| New Indication(I-896) | Jul 18, 2025 |
| Pediatric Exclusivity(PED) | Jan 18, 2026 |
Several oppositions have been filed on Opzelura's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Opzelura's generic, the next section provides detailed information on ongoing and past EP oppositions related to Opzelura patents.
Opzelura's Oppositions Filed in EPO
Opzelura has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 21, 2012, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP06839328A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16152794A | Sep, 2019 | Generics (UK) Ltd | Revoked |
| EP16197502A | Jun, 2019 | Concert Pharmaceuticals, Inc. | Granted and Under Opposition |
| EP08770794A | Dec, 2014 | Actavis Group PTC ehf | Patent maintained as amended |
| EP08770794A | Dec, 2014 | Generics [UK] Ltd (trading as Mylan) | Patent maintained as amended |
| EP06839328A | Jun, 2012 | Fresenius Kabi Deutschland GmbH | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Opzelura is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Opzelura's family patents as well as insights into ongoing legal events on those patents.
Opzelura's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Opzelura's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 05, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Opzelura Generics:
There are no approved generic versions for Opzelura as of now.
Alternative Brands for Opzelura
Opzelura which is used for treating nonsegmental vitiligo and mild to moderate atopic dermatitis in both adult and pediatric patients., has several other brand drugs using the same active ingredient (Ruxolitinib Phosphate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Opzelura
Opzelura is a drug owned by Incyte Corp. It is used for treating nonsegmental vitiligo and mild to moderate atopic dermatitis in both adult and pediatric patients. Opzelura uses Ruxolitinib Phosphate as an active ingredient. Opzelura was launched by Incyte Corp in 2021.
Approval Date:
Opzelura was approved by FDA for market use on 21 September, 2021.
Active Ingredient:
Opzelura uses Ruxolitinib Phosphate as the active ingredient. Check out other Drugs and Companies using Ruxolitinib Phosphate ingredient
Treatment:
Opzelura is used for treating nonsegmental vitiligo and mild to moderate atopic dermatitis in both adult and pediatric patients.
Dosage:
Opzelura is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1.5% BASE | CREAM | Prescription | TOPICAL |